Model Number 7601-N90003-K |
Device Problems
Mechanical Jam (2983); Failure to Eject (4010)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 01/01/2022 |
Event Type
malfunction
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Manufacturer Narrative
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This mdr is part of the fda voluntary malfunction summary reporting program.A supplemental vmsr will be submitted upon completion of the investigations.Return status of the device is unknown.
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Event Description
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This report summarizes two malfunction events where the tips of navigated yukon oct polyaxial screw inserters were sticking when trying to disengage from the screw.Surgeries were successfully completed with no delay.No adverse consequences or medical intervention were reported.
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Event Description
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This record is a consolidation of q4 2021 records summarized as a part of the fda voluntary malfunction summary reporting program.This report captures two instances of intraoperative navigated yukon screw inserter tip jamming.In both cases, the procedure was successfully completed with no adverse consequence to the patient and no surgical delay.
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Manufacturer Narrative
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The devices were not returned for evaluation.Device history records and complaint history could not be reviewed without either the device or a valid lot number.Limited information regarding the event was made available to stryker.Multiple attempts were made to obtain additional information, but no response was received.A root cause cannot be established.If additional information is received or the device is returned for evaluation, the investigation will be reopened and updated.H3 other text : device not returned.
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Search Alerts/Recalls
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